Imvexxy
NDC Package 68308-747-18
Package Information
Imvexxy is a medication a female hormone (estrogen). Marketed by Mayne Pharma, this product is identified by NDC 68308-747 and is authorized under FDA application NDA208564.
Identification & Billing
- RxCUI: 2048916 - Imvexxy 10 MCG Vaginal Insert
- RxCUI: 2048916 - estradiol 0.01 MG Vaginal Insert [Imvexxy]
- RxCUI: 2048916 - Imvexxy 0.01 MG Vaginal Insert
- RxCUI: 2048917 - estradiol 4 MCG Vaginal Insert
- RxCUI: 2048917 - estradiol 0.004 MG Vaginal Insert
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 68308 - Mayne Pharma
- 68308-747 - Imvexxy
- 68308-747-18 - 1 BLISTER PACK in 1 CARTON / 18 INSERT in 1 BLISTER PACK
- 68308-747 - Imvexxy
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Other Available Packages
The following commercial packages are registered under the same Product NDC (68308-747). Click a package code to view its specific billing and regulatory data.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 68308-747-18 identifies a specific commercial package of 1 blister pack in 1 carton / 18 insert in 1 blister pack of Imvexxy, labeled by Mayne Pharma. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Mayne Pharma on May 03, 2024. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
This medication is a female hormone (estrogen). It is used by women to help reduce vaginal symptoms of menopause (such as vaginal dryness/burning/itching). These symptoms are caused by the body making less estrogen. When treating only vaginal symptoms of menopause, products applied directly inside the vagina (such as this medication) should be used first. Estrogens that are taken by mouth, absorbed through the skin, or injected may have greater risks of side effects due to more estrogen being absorbed.
How is this Mayne Pharma product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 68308074718. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
